New Legislation Would Improve FDA Drug-Approval Process
The recent controversy over Medicare’s decision to only cover the cost of the Alzheimer’s drug Aduhelm for patients enrolled in a clinical trial approved by the Center for Medicare and Medicaid Services (CMS) or supported by the National Institutes of Health (NIH) started with a decision made by the Food and Drug Administration (FDA) last June.
In that decision, the FDA approved Aduhelm using the “accelerated approval pathway,” which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.
As a result of that FDA decision, three members of its own medical advisory committee, which had overwhelmingly voted against approving the drug, resigned in protest. One of them said the decision was wrong “because of so many different factors, starting from the fact that there’s no good evidence that the drug works.”
The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease — and that the drug could cause potentially serious side effects of brain swelling and brain bleeding.
The “accelerated approval pathway” the FDA used in that approval has come under scrutiny and last March the Chairman of the House Energy and Commerce Committee Frank Pallone, Jr. (D-N.J.) introduced legislation that seeks to ensure that drugs that enjoy a quick trip through the regulator offer “proven clinical benefit” to patients.
The FDA’s accelerated approval pathway lets the agency base approvals on certain factors other than a demonstrated clinical benefit, like extending patients’ lives. The route helps certain drugs for diseases with unmet needs, like some types of cancers and rare diseases, reach patients sooner. But companies with these drugs are required to run trials to confirm the effectiveness of the drugs after it has received the “fast-track” approval.
If those studies do not bear fruit, the FDA has procedures in place to remove the product from the market.
This past week it was revealed that a bi-partisan group of House lawmakers are moving a little closer toward cracking down on drug-makers that dishonestly use the FDA’s accelerated approval pathway.
The House Energy and Commerce Committee announced Wednesday that its sweeping user fee authorization bill will include a revised policy from Chairman Pallone that would make it easier for the Food and Drug Administration to rescind its approval for drugs cleared through the pathway when drug makers do not complete required follow-up studies.
It has been said that a disease-controlling or preventing drug does no good if you cannot afford it. It is also true that a drug that received “fast-track” approval does no good if it does not really work.
TSCL will continue to monitor this legislation as the House of Representatives further develop it.
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Home Health Care Worker Shortage Causes Concern
The number of adults aged 60 and older in the U.S. is expected to increase 30 percent by 2050. Even now, more seniors and people with disabilities are choosing to stay in their homes rather than going into institutional care.
As a result, home health aides are predicted to be one of the fastest-growing nations in the next decade.
However, there is a shortage of home health aides now and there is concern that the need for them will outstrip the number of people who are willing to go into the field.
One of the big reasons is the low pay home health workers receive and employers say they are already struggling to attract serious candidates. In fact, some fast-food restaurants, like McDonalds, now pay their employees more than some home health care workers get.
Experts say raising wages is an important first step, but it is not the only change that is needed. Home health aides need more training opportunities and support to develop specialized skills, and most do not have career opportunities that would allow them to move up into other related health care or social work positions.
Medicaid pays for many home health care workers and in order to help improve the situation the Biden administration has proposed investing $150 billion towards home health care as part of its Build Back Better Act.
But the legislation, which also contains a provision to lower drug prices by allowing Medicare to negotiate prices with drug companies, is stalled because of disagreements within Biden’s own party.
TSCL supports the legislation precisely because of the two provisions regarding drug prices and health care and we urge you to contact your senators, especially if you live in West Virginia, and urge them to find a way to pass the bill this year.
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“New Normal” May Mean Annual Covid Vaccinations
Officials from the Food and Drug Administration (FDA) announced last week that the United States might need to update its Covid-19 vaccines each year, and "a new normal" may include an annual Covid-19 vaccine alongside a seasonal flu shot.
Since the covid pandemic began multiple variants of the virus have developed. And since seniors have suffered the most deaths of any group, we are sharing with you a guide to the variants that have arisen so far. The guide was published by Kaiser Health News and can be reached by clicking here: Kaiser Health News Article
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As we continue dealing with the Covid 19 pandemic, TSCL remains constant in our fight for you to protect your Social Security, Medicare, and Medicaid benefits. We’ve had to make some adjustments in the way we carry on our work, but we have not, and will not stop our work on your behalf.
For progress updates or for more information about these and other bills that would strengthen Social Security and Medicare programs, visit our website at www.SeniorsLeague.org or follow TSCL Facebook or on Twitter.
